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NCT01769118 Clinical Trial

The Influences of Caffeine on Heart Rate Variability of Preterm Infants

Autonomic Nervous System Clinical Trial

Official title:
The Influences of Caffeine on HRV of Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01769118
Other study ID # 0442-12
Secondary ID
Status Completed
Phase N/A
First received January 14, 2013
Last updated May 6, 2015
Start date January 2013
Est. completion date January 2014

Study information
Verified date May 2015
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

Caffeine has a stimulatory effect on the ANS. This has not yet been investigated in preterm infant who get caffeine before stopping ventilation. The investigators hypothesis is that this stimulatory effect may be characterized by HRV analysis methods.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 25 Weeks to 34 Weeks
Eligibility Inclusion Criteria:

- infants born before 34 weeks gestation

Exclusion Criteria:

- sepsis

- congenital malformations

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Caffeine
Caffeine will be given according to departmental protocol

Locations
Country Name City State
Israel RMC Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Heart rate variability Heart rate, SD, SDNN, HF, LF, VLF, TP 1 hour No
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